Immunization Registry Content

Introduction

This is a draft of the Immunization Registry Content Profile (IRC) supplement to the PCC Technical Framework. This draft is a work in progress, not the official supplement or profile.

Profile Abstract

The Immunization Content Profile (IC)

The Immunization Content Profile defines standard immunization data content for Immunization Information Systems (IISs), other public health systems, electronic medical records (EMR) systems, Health Information Exchanges, and others wishing to exchange immunization data electronically in a standard format.

Glossary

Immunization Information System (IIS)

Preferred term of the American Immunization Registry Association for "Immunization Registry"

Issue Log

Open Issues

1. In preparation for the development of this profile, the compatibility of HL7 Version 3 POIZ and CareRecord were analyzed. The standards were found to be highly compatible. A few differences were identified and referred back to the HL7 Public Health and Emergency Response (PHER) Work Group for resolution through comments on both Draft Standards for Trial Use (DSTU). The approach taken in the Immunization Content (IC) Profile is to update the current Immunization Summary template provided in QED to contain all the fields in POIZ and to use POIZ tags (in order to best reflect terminology created by immunization and public health domain experts). The updated template is the equivalent of a POIZ template on CareRecord.
2. Care Management (CM) provides the notification-based integration profile for HL7 V2 immunization messages (VXQ/VXX/VXR). Query for Existing Data (QED) provides a query-based integration profile for the HL7 V3 portions of this profile, but doesn't include an option for HL7 V2. Thus, we still don't have a query option for V2. We are asking for public comment on this point.
3. This IC profile contains three options for each actor. This has been thought to be problematic because two systems implementing different options may not be able to communicate. Another approach would be to break this profile into two, one for HL7 Version 2, and one for HL7 Version 3 (combining the Immunization Summary and Care Record options into one). Public comment on this issue is sought.
4. We see this as a two-part exercise: (1) update of the existing IHE Immunization Summary template to reflect missing POIZ fields; and (2) creation of a new profile that includes Allergies, Problems, etc. - something that looks more like a discharge summary or a transfer of care summary, etc.

Notes to Author/Editor (do not include in final drafts)

1. V2.3.1 messages blend identity resolution with transmission of clinical data. Profiles such as QED and CM do not handle identity management; this is the purview of PIX and PDQ. How then is this aspect of HL7 Version 2.3.1 to be handled?
2. Note that HL7 "V2" below refers to "V2.3.1". Note that an implementation guide for HL7 V2.5 is also under development in the U.S. Centers for Disease Control (CDC).
3. Address how to handle updates to referenced V2 Guides.
4. Template for Advanced Directives needs to be fixed to include Immunization Refusal Reasons.
5. Template for Immunizations needs to be fixed to include Lot #, Manufacturer, and Expiration Date.
6. POIZ DSTU includes a "subject" tag that is redundant with the "patient" tag in Care Record, and is stated to be "required." We want to omit or ignore it, since it is redundant in the Care Record context.
7. POIZ DSTU appears to use different tagnames for "author" and "informant" than PCC defines them in section 6.4.4.1. PCC-2 samples (e.g.:6.4.4.20) and specs (6.4.4.1) show:

           <author typeCode='AUT'>
             <assignedEntity classCode='ASSIGNED'>
               <id root= extension=/>
               <addr></addr>
               <telecom use= value=/>
               <assignedPerson classCode='PSN'>
                 <name>…</name>
               </assignedPerson>
               <representedOrganization>
                 <name>...</name>
               </representedOrganization>
             </assignedEntity>
           </author>

versus POIZ, which appears to me to show in POIZ_HD030050UV and COCT_MT090107UV:

       <author typeCode='AUT' contextControlCode='OP'>
           <assignedPerson classCode='ASSIGNED'>
               <id root= extension=/>
                 
               <addr></addr>
               <telecom use= value=/>
               <person classCode='PSN' determinerCode='INSTANCE'>
                   <name>...</name>
               </person>
               <representedOrganization classCode='ORG'
                                    determinerCode='INSTANCE'>
                   <name>...</name>
               </representedOrganization>
           </assignedPerson>
       </author>

Although the structures are the same (with the addition of a Role code in POIZ), the tagnames are different than those used for author in Care Record. Also, some of the PCC-2 samples show other tagnames for author (e.g.: 6.4.4.6). Is this an issue?

Closed Issues

1. Important elements are currently missing from the PCC QED immunization template, for example, the person who gave the shot. CareRecord can include person who administered vaccine in Performer role. This will be resolved by updating the current immunization template.

Volume I

Add the following bullet to the list of profiles

• Immunization Content - The Immunization Content Profile defines standard immunization data content for Immunization Information Systems, other public health systems, EMR systems, Health Information Exchanges, and others wishing to exchange immunization data electronically in a standard format.

Dependencies

Add the following row(s) to the list of dependencies

Integration Profile	Dependency	Dependency Type	Purpose
Immunization Content Content	ATNA CT

The Immunization Content Profile (IC)

The Immunization Content Profile (IC) provides a standard message, document and web service formats for exchanging immunization data. It is intended to facilitate the exchange of immunization data among multiple systems belonging to a single or to multiple organizations. Data exchange with and among the installed base of U.S. Immunization Information System (IIS) base was a critical consideration in formulating this profile. However, its intention is to go beyond data exchange among IISs, and facilitate immunization data exchange on a healthcare information network that includes electronic medical record (EMR) systems, Health Information Exchanges, other public health systems, Personal Health Record (PHR) systems, and other stakeholder systems. Thus, the profile specifies common data formats for exchanging immunization data only, or for exchanging immunization data along with medical summary data needed for the overall care of a patient related to immunizations.

To accomplish this, IC draws from two HL7 Version 3 message standards: Immunizations and Care Provision. Immunizations contains a message information model which handles detailed immunization information only. It includes history of administered vaccines with such details as lot number, who administered the shot, and so forth. Care Provision contains a message information model which handles immunization as well as other information related to the patient's care. For example, it includes medical history, medications, allergies, vital signs, and so forth. To provide for compatibility with the U.S. installed base of Immunization Information Systems (IISs), an HL7 Version 2.3.1 content option is also included.

The format of data is treated here as a separate topic from whether the data communicated in message, service, or document format, or whether an enclosing message is query-based or notification-based. By isolating content description from transaction description, the same content can be exchanged both in query and notification (unsolicited update) transaction styles, or in a service. IC is intended to be used in conjunction with integration profiles such as Query for Existing Data (QED) and Care Management (CM) to create architectures for immunization information exchange. It is also hoped that in the future, IC can be used in document-oriented profiles such as XDS. Finally, the IC Profile is also intended to pave the way for content to be passed to immunization-related decision support services. Decision support, however, is out of scope for the 2007-2009 IHE cycle and is on the IHE roadmap for the future.

Use Cases

The following progression of use cases is illustrated in the drawing below.

-->>insert Drawing for Public Comment here<<--

Use Case 1: Immunization Information System Participation

Various provider organizations - airport flu shot clinics, storefront vaccine clinics, and hospital vaccine clinics - wish to submit immunization histories for patients to a regional Immunization Information System (IIS) with appropriate patient consent. The provider IT departments configure HL7 Verion 2.3.1 connections with the IIS. Each time immunizations are recorded, records of the administered vaccines are automatically sent to the IIS using an HL7 version 2.3.1 standard format.

This is representative of the present-state use case in the U.S.

Use Case 2: Immunization Yellow Card

A pediatrician's office produces official immunization records (sometimes called "Yellow Card") for patients. The provider electronic medical record (EMR) system retrieves demographic information and records of immunization its immunization repository. To supplement its records with immunizations that the patient may have received from other providers, it queries the regional Immunization Information System (IIS). It passes the immunization content to a software module or service that prints the information in the official Yellow Card format.

Use Case 3: Personal Health Record

The provider wishes to make the assembled immunization information available in the patient's Personal Health Record (PHR). The pediatrician's office EMR system includes the retrieved immunization information in its complete care provision information about the patient. The standard Care Provision information contains current conditions, allergies and past adverse events, medications, vital signs, past medical history such as disease history, and so forth, in addition to immunizations. Knowing that the patient also has visited providers in a neighboring state, the EMR system queries the neighboring state's Health Information Exchange (HIE) to retrieve additional care provision information in a standard format. Since the neighboring state IIS is also part of the HIE, the retrieved information also includes immunizations. The pediatrician's office EMR system combines the retrieved and local information and sends it to the provider's PHR system in a standard format.

Use Case 4: Vaccine Forecast

The pediatrician's office wishes to run an automated Vaccine Forecast Decision Support Service to calculate which vaccines due on the next visit, and to assist with reminder/recall. The service may be integrated within the EMR or may be accessed externally using a web service interface. The service accepts a standard XML-based payload in Immunization Content format. The pediatrician's EMR system submits the patients Care Provision data that it has previously assembled to the Vaccine Forecast Decision Support Service and receives a vaccine forecast care plan in return. It records the care plan and uses it in reminder/recall.

Actors/Transaction

There are two actors in this profile, the Content Creator and the Content Consumer. Content is created by a Content Creator and is to be consumed by a Content Consumer. The sharing or transmission of content from one actor to the other is addressed by the appropriate use of IHE profiles described below, and is out of scope of this profile.

Immunization Registry Content Actor Diagram

Options

Immunization Content Options

Actor	Option	Section
Content Consumer	Immunization Summary Option (1) Care Record Option (1) HL7 V2 Option (1)	PCC TF-1: X.X.X PCC TF-1: X.X.X PCC TF-1: X.X.X
Content Creator	Immunization Summary Option (1) Care Record Option (1) HL7 V2 Option (1)	PCC TF-1: X.X.X PCC TF-1: X.X.X PCC TF-1: X.X.X

Note ¹: The Actor shall support at least one of these options.

Volume II

Immunization Content

Standards

Implementation Guide for Immunization Data Transactions Using V 2.3.1 of the Health Level Seven (HL7) Standard Protocol

Implementation Guide for Immunization Data Transactions Using V 2.3.1 of the Health Level Seven (HL7) Standard Protocol.

HSSP Retrieve, Locate and Update Service

Implementation Service Functional Model (SFM), balloted HL7 Draft Standard for Trial Use (DSTU) HL7.

HSSP Retrieve, Locate and Update Service

Initial submission to OMG includes a profile that demonstrates immunization data retrieval and update in conformance to SFM

HL7 V3 Immunizations (Click on Universal Domains, Immunizations)

HL7 Version 3 Standard: Immunization, Release 1 DSTU Ballot 3 - May 2008

HL7 V3 Care Provision (Click on Universal Domains, Care Provision)

HL7 Version 3 Standard: Care Provision, Release 1 Last Ballot: DSTU Ballot 3 - September 2007

Data Element Index

-->>We want to add definitions to all of the element names. Some may be self-explanatory<<--

Existing Common Care Record Elements Required for Immunization Content

Data Elements	Other Reference	Care Record Element
Patient ID	not required for Vaccine Forecast Decision Support	patient.id
DOB	only required for Vaccine Forecast Decision Support	patient.birthTime
Gender	only required for Vaccine Forecast Decision Support	patient.administrativeGender

Immunization Content Data Elements based on POIZ

Data Elements	Other Reference	Care Record Element
Immunization Record ID	instance identifier	immunization.id
Negation Indicator		immunization.negationInd
Description		immunization.text
Immunization Date		immunization.effectiveTime
Confidentiality Code		immunization.confidentialityCode
Uncertainty Code		immunization.uncertaintyCode
Dose Quantity		immunization.doseQuantity.value - units
Route		immunization.routeCode
Approach Site		immunization.approachSiteCode
Vaccine Code	CDC CVX code in US	administerableMaterial.code
Vaccine Name		administerableMaterial.name
Vaccine Lot #		administerableMaterial.lotNumberText
Vaccine Expiration Date		administerableMaterial.expirationTime
Manufacturer ID	CDC MVX code in US	asMedicineManufacturer.manufacturer.id
Manufacturer name		asMedicineManufacturer.manufacturer.name
Vaccine Lot # Recalled Observation		???
Performer ID		performer.assignedPerson.id
Performer Name		performer.assignedPerson.assignedPrincipalChoice List.person.name
Performer Organization ID		performer.assignedPerson.representedOrganization.id
Performer Organization Name		performer.assignedPerson.representedOrganization.name
Author ID		author.assignedPerson.id
Author Role		author.role.code
Author Name		author.person.name
Informant Name		informant.person.name
Informant Mode	written/verbal/electronic	informant.modeCode
Informant Source	patient/relative/provider	informant.informationSourceCode
Vaccine Information Statement Given		observation.code
VIS Version		observation.value
Reason Not Administered		reason.noImmunizationReason.reasonCode
Shot Comments / Notes		annotation.text

Existing Problem Record Data Elements

Data Elements	Other Reference	Care Record Element
ID		problems.id
Problem began		problems.effectiveTime.low
Problem ended		problems.effectiveTime.high
Problem Type	SNOMED CT type of problem	problems.code
Confidentiality Code		problems.confidentialityCode
Uncertainty Code		problems.uncertaintyCode
Problem Code	ICD-9 or SNOMED problem code	problems.value
Severity		problems.severity
Clinical Status		problems.clinicalStatus
Health Status		problems.healthStatus
Comments		problems.comments

Existing Allergy and Intolerance Data Elements

Data Elements	Other Reference	Care Record Element
ID		intolerance.id
Intolerance Type	ObservationIntoleranceType	intolerances.code
Allergy Code	ICD-9 or SNOMED allergy code	intolerances.value
Allergen Substance	substance causing allergy	intolerances.participant.code
Allergic Reaction History		intolerances.reactions
Severity		intolerances.severity
Clinical Status		intolerances.clinicalStatus
Comments		intolerances.comments

Existing Medications Data Elements

Data Elements	Other Reference	Care Record Element
ID		medications.id
Description		medications.text
Date Range		medications.effectiveTime
Drug Code		administeredMaterial.code
Drug Name		administeredMaterial.name

Existing Simple Observations for Labs

Data Elements	Other Reference	Care Record Element
ID		labs.id
Lab Code		labs.code
Description		labs.text
Date		labs.effectiveTime
Result		labs.value
Result Interpretation		labs.interpretationCode
Test Method		labs.methodCode
Author ID		labs.author.id
Author Name		labs.author.name

Existing Vital Signs Data Elements

Data Elements	Other Reference	Care Record Element
Observation Date		vitalSigns.organizer.effectiveTime
Observation by		vitalSigns.organizer.author
ID		vitalSigns.id
Observation Code	LOINC: 8310-5 body temp	vitalSigns.code
Observation Value - Units		vitalSigns.value

Existing Pregnancy Data Elements

Data Elements	Other Reference	Care Record Element
ID		pregnancy.id
Observation Date		pregnancy.effectiveTime
Pregnancy Info Type	LOINC: 11449-6 Pregnancy Status	pregnancy.code
Pregnancy Status		pregnancy.value
Pregnancy Info Type	LOINC: <several codes> Estimated Delivery Date	pregnancy.code
Estimated Due Date		pregnancy.value

Existing Advanced Directives Data Elements

Data Elements	Other Reference	Care Record Element
ID		advanceDirectives.id
Scope (Refusal Reason Code)	<additions to list of SNOMED code(s) to include IZ Refusal Reasons>	advanceDirectives.code
Scope Permitted?		advanceDirectives.value
Description		advanceDirectives.text
Effective From Date		advanceDirectives.effectiveTime.low
Effective Thru Date		advanceDirectives.effectiveTime.high
Comments		advanceDirectives.comments

Update Entry

Data Elements	Other Reference	Care Record Element
Type Code	replace or append	reference.typeCode
Referenced Act ID	ii	reference.externalAct.id

Document Specification

Immunization Content Constraints

Data Element	Opt	PCC Section	Template ID
Original Care Record	R
Patient ID	C		Not Required for Vaccine Forecast Decision Support
DOB	C		Only Required for Vaccine Forecast Decision Support
Gender	C		Only Required for Vaccine Forecast Decision Support
History of Immunizations (POIZ)	R		1.3.6.1.4.1.19376.1.5.3.1.4.??
Immunization Record ID	R
Negation Indicator	R
Description	R
Immunization Date	R
Confidentiality Code	R2
Uncertainty Code	R2
Dose Quantity	R2
Route	R2
Approach Site	R2
Vaccine Code	R	CDC CVX	2.16.840.1.113883.6.59
Vaccine Name	R2
Vaccine Lot #	R2
Vaccine Expiration Date	R2
Manufacturer ID	R2
Performer Person ID	R2
Performer Person Name	O
Performer Organization ID	R2
Performer Organization Name	O
Author	R2	6.4.4.1
Informant	R2	6.4.4.1
Vaccine Information Statement Given	R2
VIS Version	R2
Reason Not Administered	R2
Comments about Shot	R2	6.4.4.6	1.3.6.1.4.1.19376.1.5.3.1.4.2
Authors and Informants	R2	6.4.4.1
ID	R
Address	R
Telecom	R
Role Code	R2
Name	O
Informant Mode	R2
Informant Source	R2
Problem Entry	R2	6.4.4.14	1.3.6.1.4.1.19376.1.5.3.1.4.5
ID	R
Problem began	R2
Problem ended	R2
Problem Type	R2
Confidentiality Code	R2
Uncertainty Code	R2
Problem Code	R
Severity	R2	6.4.4.3	1.3.6.1.4.1.19376.1.5.3.1.4.1
Clinical Status	O	6.4.4.4	1.3.6.1.4.1.19376.1.5.3.1.4.1.1
Health Status	O	6.4.4.5	1.3.6.1.4.1.19376.1.5.3.1.4.1.2
Comments	O	6.4.4.6	1.3.6.1.4.1.19376.1.5.3.1.4.2
Allergies and Intolerances	R2	6.4.4.15	1.3.6.1.4.1.19376.1.5.3.1.4.6
ID	R
Intolerance Type	R
Allergy Code	R
Allergen Substance	R2
Allergic Reaction History	R2
Severity	R2	6.4.4.3	1.3.6.1.4.1.19376.1.5.3.1.4.1
Clinical Status	O	6.4.4.4	1.3.6.1.4.1.19376.1.5.3.1.4.1.1
Comments	O	6.4.4.6	1.3.6.1.4.1.19376.1.5.3.1.4.2
Medications	R2	6.4.4.16	1.3.6.1.4.1.19376.1.5.3.1.4.7
ID	R
Description	R2
Date Range	R
Drug Code	R2
Drug Name	R2
Lab Results	R2	6.4.4.16	1.3.6.1.4.1.19376.1.5.3.1.4.13
ID	R
Lab Code	R
Description	R2
Date	R
Result	R2
Result Interpretation	R2
Test Method	R2
Author	R2	6.4.4.1
Vital Signs Organizer	R2	6.4.4.21	1.3.6.1.4.1.19376.1.5.3.1.4.13.1
Observation Date	R
Observation by	R2
Vital Signs Observation	R2	6.4.4.22	1.3.6.1.4.1.19376.1.5.3.1.4.13.2
ID	R
Observation Code	R	LOINC: 8310-5 body temp	vitalSigns.code
Observation Value - Units	R
Pregnancy Observation	R2	6.4.4.26	1.3.6.1.4.1.19376.1.5.3.1.4.13.5
ID	R
Observation Date	R
Pregnancy Info Type	R2
Pregnancy Status	R2
Pregnancy Info Type	R2
Estimated Due Date	R2
Advance Directive Observation	R2	6.4.4.28	1.3.6.1.4.1.19376.1.5.3.1.4.13.7
ID	R
Refusal Reason Code	R	6.4.4.28.4	<need to expand SNOMED list to include vaccines, refusal reasons, etc.>
Reason Code Permits Immunization?	R2
Effective From Date	R2
Effective Thru Date	R2
Comments	O	6.4.4.6	1.3.6.1.4.1.19376.1.5.3.1.4.2
Update Entry	C	6.4.4.31	1.3.6.1.4.1.19376.1.5.3.1.4.16
Type Code	R	6.4.4.31.3	RPLC or APND
Referenced Act ID	R	6.4.4.31.5	id of section being replaced or appended to

Immunization Content Section

TemplateID	1.3.6.1.4.1.19376.1.5.3.1.?.?
Parent Template	CCD 3.11(2.16.840.1.113883.10.20.1.6)
General Description	This section shall contain a full description of the immunizations administered to the patient in the past. It shall include entries for medication administration as described in the Entry Content Module. It shall also contain all known medical information which is relevant to past and future immunization decisions for the patient.
LOINC Code	Opt	Description
11369-6	R	HISTORY OF IMMUNIZATIONS
Entries	Opt	Description
1.3.6.1.4.1.19376.1.5.3.1.?.?	R	Immunization Content
Sub-sections	Opt	Description
1.3.6.1.4.1.19376.1.5.3.1.?.?	R	History of Immunizations (POIZ) (if no immunizations have been given, that fact must be stated with negationInd = true, and NoImmunizationReason supplied)
Sub-sections	Opt	Description
1.3.6.1.4.1.19376.1.5.3.1.4.5	R2	Problems and Conditions
Sub-sections	Opt	Description
11.3.6.1.4.1.19376.1.5.3.1.4.6	R	Allergies and Intolerances (allergy to eggs must be specified, whether positive, negative, or unknown) (any known reactions to vaccine events must be specified, and linked to the particular immunization event, if known)
Sub-sections	Opt	Description
1.3.6.1.4.1.19376.1.5.3.1.4.7	R2	Medications
Sub-sections	Opt	Description
1.3.6.1.4.1.19376.1.5.3.1.4.13.1	R2	Vital Signs Organizer
Sub-sections	Opt	Description
1.3.6.1.4.1.19376.1.5.3.1.4.13.2	R2	Vital Signs Observation
Sub-sections	Opt	Description
1.3.6.1.4.1.19376.1.5.3.1.4.13.5	C	Pregnancy Observation
Sub-sections	Opt	Description
1.3.6.1.4.1.19376.1.5.3.1.4.13.7	R2	Advance Directives and Consent Observation
Sub-sub-sections	Opt	Description
1.3.6.1.4.1.19376.1.5.3.1.4.1	R2	Severity (used in Problems and Allergies)
Sub-sub-sections	Opt	Description
1.3.6.1.4.1.19376.1.5.3.1.4.1.1	R2	Clinical Status (used in Problems and Allergies)
Sub-sub-sections	Opt	Description
1.3.6.1.4.1.19376.1.5.3.1.4.1.2	R2	Health Status (used in Problems)
Sub-sub-sections	Opt	Description
1.3.6.1.4.1.19376.1.5.3.1.4.2	R2	Comments (used in POIZ, Problems, Allergies and Advance Directives)

Parent Template

-->>do we need this?<<--

<entry>An XML Example</entry>

entry

The parent of this template is CCD 3.11.

SampleMessages

Sample V3 Message

-->>insert ImmunizationRegistryContent 052808.xml from discussion page<<--

Sample V2 Message

See Implementation Guide for Immunization Data Transactions Using V 2.3.1 of the Health Level Seven (HL7) Standard Protocol, referenced in Standards above.